Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia

NCT06149013 | Completed

• 1 other identifier: MiMo-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.

Conditions

Mild Cognitive Impairment; Mild Dementia

Keywords

Behavioral Activation Therapy; Active lifestyle intervention

Outcome Measures

Primary Outcomes (2)

• Overall Quality of Life

  Change in quality of life (total score of generic and disorder-specific quality of life) from baseline to 3-month follow-up. Overall quality of life will be measured with a composite score of all items of the World Health Organization WHOQOL-BREF quality of life assessment and the Dementia Quality of Life (DEMQOL). All items will be transformed to a scale ranging from 0 to 100 and subsequently averaged. Higher scores indicate a higher quality of life.

  3 months

• Activity Level

  Change in activity level (total score of social, physical and cognitive activity level) from baseline to 3-month follow-up. Overall activity level will be measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) German version. The CHAMPS assesses frequency and duration of 41 physical, cognitive, and social activities of a typical week within the last 4 weeks. As measure for activity level, we assess the total hours spend per week covering all performed 41 activities, by adding up the data on activity duration (as described by Poelke, et al., 2016, International Psychogeriatrics). Therefore, the duration scale for each item is transformed as described in the original work by Stewart et al. (2001, Medicine and Science in Sports and Exercise), with category 1 = 0.5 hours, 2 = 1.75 hours, 3 = 3.75 hours, 4 = 5.75 hours, 5 = 7.75 hours, and 6 = 9.75 hours. The composite score can range from 0 to 399.75 hours per week.

  3 months

Secondary Outcomes (17)

• Disorder-specific quality of life

  3 months

• Generic quality of life - composite score

  3 months

• Generic quality of life - physical health subscale

  3 months

• Generic quality of life - psychological health subscale

  3 months

• Generic quality of life - social relationships subscale

  3 months

Other Outcomes (11)

• Daily functioning

  3 months

• General patient satisfaction

  3 months

• Screening time

  3 months

Study Arms (2)

MindAhead + TAU Group

EXPERIMENTAL

The intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention).

Device: MindAhead Active; Other: Treatment-as-usual

TAU Group

ACTIVE COMPARATOR

The control group receives TAU which may include antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins depending on clinical findings.

Other: Treatment-as-usual

Interventions

MindAhead Active DEVICE

MindAhead's Active app focuses on increasing meaningful and enjoyable cognitive, physical, and social activities specifically adapted to patients with early cognitive decline (MCI or mild dementia). These techniques include psychoeducation (explaining the rationale, the components of behavioral activation, and protective activities), action planning (selecting activities, goal setting, activity scheduling, graded task assignment, written schedules, and step-by-step sequencing) and action/self-monitoring (assessing execution of and enjoyment in activities, monitor mood and cognitive problems), as well as value-based activation (understanding most important values, selecting activities according to these values). This process aims to enable the users to understand which activities are enjoyable and meaningful to them and how to implement these activities into their daily lives. MindAhead's Active app consists of one to five sessions per week.

Also known as: MindAhead's Behavioral Activation Therapy

MindAhead + TAU Group

Treatment-as-usual OTHER

Depending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins.

Also known as: TAU

MindAhead + TAU Group; TAU Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or mild dementia stage (ICD-10: F00.-\*, F01.-, F03) due to all etiologies apart from etiologies described in F02.- (Pick's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCI and mild dementia include
• Alzheimer's disease (e.g., F00.-\*)
• Vascular disease (e.g., F01.-) (exception in case of stroke: event occurred \> 12 months ago without ongoing spontaneous remission)
• Mixed diseases
• Unclear etiologies
• MCI or mild dementia diagnosis assigned within the last 12 months by a neurologist or psychiatrist from our cooperation partners that fulfil adequate diagnosis procedures such as neuropsychological assessment, brain imaging, self- and/or third-party medical history interview, and potentially cerebrospinal fluid, positron emission tomography, or electrophysiological measures
• MCI or mild dementia diagnosis confirmed by a treating physician
• MMSE ≥ 24 or MoCA ≥ 18 (last date of assessment is decisive; needs to be within the last 12 months)
• Sufficient physical fitness to engage in physical activities (e.g., walking or cycling) as confirmed by a treating physician
• Age ≥ 50
• German language skills sufficient to understand German instructions of study assessments and of the intervention
• Ability and sufficient vision to operate a smartphone

You may not qualify if:

• possibly moderate or severe cognitive impairment (moderate or severe dementia), indicated by MMSE \< 24 or MoCA \< 18 (last date of assessment is decisive; needs to be within the last 12 months)
• Specific brain injury events within the last 12 months or with ongoing spontaneous remission due to
• Stroke (ischemic, hemorrhagic)
• Traumatic brain injury
• Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or a fast progression including
• Multiple sclerosis
• Parkinson's disease
• Pick's disease / Frontotemporal lobar degeneration
• Lewy body disease
• Brain tumors
• Autosomal dominant form of Alzheimer's disease with early first manifestation
• Creutzfeldt-Jakob disease
• German language restrictions or visual restrictions which prevent from understanding written German instructions of assessment or intervention procedures (e.g. severe aphasia, lack of sufficient German language skills, severe non-corrected visual impairment)

Sponsors & Collaborators

• MindAhead UG: lead
• University Medical Center Göttingen: collaborator

Study Sites (1)

University Medical Center Göttingen

Göttingen, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jens Wiltfang, Prof. Dr.

  University Medical Center Göttingen, Clinic for Psychiatry and Psychotherapy, Germany

  PRINCIPAL INVESTIGATOR

• Christine A.F. von Arnim, Prof. Dr.

  University Medical Center Göttingen, Clinic for Geriatrics, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 28, 2023
• Study Start: December 21, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

DE (1)